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Trabectedin for Patients with Advanced Soft Tissue Sarcoma: a Non-Interventional, Retrospective, Multicenter Study of the Italian Sarcoma Group

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Trabectedin for Patients with Advanced Soft Tissue Sarcoma: a Non-Interventional, Retrospective, Multicenter Study of the Italian Sarcoma Group cancers Article Trabectedin for Patients with Advanced Soft Tissue Sarcoma: A Non-Interventional, Retrospective, Multicenter Study of the Italian Sarcoma Group Emanuela Palmerini 1,* , Roberta Sanfilippo 2, Giovanni Grignani 3 , Angela Buonadonna 4 , Antonella Romanini 5, Giuseppe Badalamenti 6 , Virginia Ferraresi 7, Bruno Vincenzi 8, Alessandro Comandone 9, Antonio Pizzolorusso 10, Antonella Brunello 11 , Fabio Gelsomino 12, Tommaso De Pas 13 , Toni Ibrahim 14 , Federica Grosso 15, Francesca Zanelli 16, Maria Abbondanza Pantaleo 17, Laura Milesi 18, Libero Ciuffreda 19, Vittorio Ferrari 20, Emanuela Marchesi 21, Irene Quattrini 1, Alberto Righi 22 , Elisabetta Setola 22,23 , Elisa Carretta 1 , Piero Picci 24 and Stefano Ferrari 1 1 Chemotherapy Unit, IRCCS Istituto Ortopedico Rizzoli, 1 Via Pupilli, 40136 Bologna, Italy; [email protected] (I.Q.); [email protected] (E.C.); [email protected] (S.F.) 2 Department of Cancer Medicine, Fondazione IRCCS Istituto Nazionale dei Tumori, Via Giacomo Venezian, 1, 20133 Milano, Italy; Roberta.Sanfi[email protected] 3 Division of Medical Oncology, Candiolo Cancer Institute, FPO-IRCCS, Strada Provinciale 142, Candiolo, 10060 Torino, Italy; [email protected] 4 Centro di Riferimento Oncologico di Aviano (CRO Aviano), IRCCS, Via Franco Gallini 2, 33081 Aviano, Italy; Citation: Palmerini, E.; Sanfilippo, [email protected] R.; Grignani, G.; Buonadonna, A.; 5 Azienda Ospedaliero-Universitaria Pisana, Via Roma 67, 56126 Pisa, Italy; [email protected] Romanini, A.; Badalamenti, G.; 6 Department of Surgical, Oncological and Oral Sciences, Section of Medical Oncology, University of Palermo, Ferraresi, V.; Vincenzi, B.; Piazza Marina 61, 90133 Palermo, Italy; [email protected] 7 Comandone, A.; Pizzolorusso, A.; IRCCS Regina Elena National Cancer Institute-Division of Medical Oncology 1-Via Elio Chianesi 53, et al. Trabectedin for Patients with 00144 Rome, Italy; [email protected] 8 Medical Oncology, University Campus Bio-Medico, Via Alvaro del Portillo 200, 00128 Rome, Italy; Advanced Soft Tissue Sarcoma: A [email protected] Non-Interventional, Retrospective, 9 SC Oncologia ASL Città di Torino, Ospedale San Giovanni Bosco Torino, Piazza del Donatore di Sangu, 3, Multicenter Study of the Italian 10154 Torino, Italy; [email protected] Sarcoma Group. Cancers 2021, 13, 10 Istituto Nazionale Tumori IRCCS “Fondazione G. Pascale”, Via Mariano Semmola 53, 80131 Naples, Italy; 1053. https://doi.org/10.3390/ [email protected] cancers13051053 11 Oncology 1 Unit, Istituto Oncologico Veneto IOV–IRCCS, Via Gattamelata 64, 35128 Padova, Italy; [email protected] 12 Academic Editors: Winan J. van Department of Oncology and Hematology, University Hospital of Modena, Via del Pozzo 71, Houdt and Bernd Kasper 41124 Modena, Italy; [email protected] 13 Unit of Medical Oncology Sarcomas, Thymomas and Rare Tumors, European Institute of Oncology, IRCCS, Via Ripamonti 435, 20121 Milano, Italy; [email protected] Received: 4 February 2021 14 Osteoncology and Rare Tumors Center, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Accepted: 25 February 2021 Amadori”, Via Piero Maroncelli 40, 47014 Meldola, Italy; [email protected] Published: 2 March 2021 15 Mesothelioma and Rare Cancer Unit, Azienda Ospedaliera SS. Antonio e Biagio General Hospital, Via Venezia, 16, 15121 Alessandria, Italy; [email protected] Publisher’s Note: MDPI stays neutral 16 Dipartimento Oncologico e Tecnologie Avanzate, Arcispedale Santa Maria Nuova IRCCS Reggio Emilia, with regard to jurisdictional claims in Viale Risorgimento 80, 42123 Reggio Emilia, Italy; [email protected] 17 published maps and institutional affil- Division of Oncology, IRCSS Azienda Ospedaliero-Universitaria di Bologna, Via Albertoni 15, 40138 Bologna, Italy; [email protected] iations. 18 Depatement of Oncology, ASST. Papa Giovanni XXIII Hospital, Piazza OMS, 1, 24127 Bergamo, Italy; [email protected] 19 Medical Oncology Unit, Azienda Ospedaliero Universitaria San Giovanni Battista, Molinette, Via Santena 5, 10126 Torino, Italy; [email protected] 20 Copyright: © 2021 by the authors. Dipartimento di Specialità Medico-Chirurgiche, Scienze Radiologiche e Sanità Pubblica, Oncologia Medica, Università degli Studi di Brescia, ASST Spedali Civili, Piazzale Spedali Civili 1, 25123 Brescia, Italy; Licensee MDPI, Basel, Switzerland. [email protected] This article is an open access article 21 Italian Sarcoma Group Clinical Trial Unit, IRCCS Istituto Ortopedico Rizzoli, Via Pupilli 1, distributed under the terms and 40136 Bologna, Italy; [email protected] conditions of the Creative Commons 22 Department of Pathology, IRCCS Istituto Ortopedico Rizzoli, Via di Barbiano 1/10, 40136 Bologna, Italy; Attribution (CC BY) license (https:// [email protected] (A.R.); [email protected] or [email protected] (E.S.) creativecommons.org/licenses/by/ 23 Department of Experimental, Diagnostic an Speciality Medicine, Alma Mater Studiorum, University of 4.0/). Bologna, Via Zamboni, 33, 40126 Bologna, Italy Cancers 2021, 13, 1053. https://doi.org/10.3390/cancers13051053 https://www.mdpi.com/journal/cancers Cancers 2021, 13, 1053 2 of 15 24 Laboratory of Oncologic Research, IRCCS Istituto Ortopedico Rizzoli, Via di Barbiano 1/10, 40136 Bologna, Italy; [email protected] * Correspondence: [email protected]; Tel.: +39-051-6366400 Simple Summary: Active therapeutic options in advanced soft tissue sarcoma (STS), able to induce durable objective responses, are scarce beyond first-line chemotherapy. Thus, new strategies and optimal sequencing in the treatment algorithm for sarcoma represents an utmost clinical challenge. This non-interventional, retrospective, multicenter study of the Italian sarcoma group aimed to provide insights of the real-world efficacy, toxicity, and management of patients with advanced STS treated with trabectedin in clinical practice across Italy. Our findings on 512 pretreated metastatic patients with multiple sarcoma histologies in terms of time-to-event outcomes (median progression- free survival of 5.1 months and median overall survival of 21.6 months) confirm the activity of this regimen in a real-life setting with a manageable and well-characterized safety profile. Our study has corroborated that in real-life clinical practice, trabectedin is mostly given as a second-line treatment to patients with a good performance status and high-grade, metastatic leiomyosarcoma and liposarcoma. Abstract: The Italian Sarcoma Group performed this retrospective analysis of patients with ad- vanced soft tissue sarcoma, pretreated with ≥1 anthracycline-based treatment, and treated with trabectedin every three weeks. Primary endpoint was to describe real-life use of trabectedin across Italy. Secondary endpoints included objective response rate (ORR) and safety. Overall, 512 patients from 20 Italian centers were evaluated. Leiomyosarcoma (37.7%)/liposarcoma (30.3%) were the most prevalent histological types (abbreviated as L-sarcoma). Patients received a median of four trabectedin cycles (range: 1–40), mostly as a second-line treatment (~60% of patients). The ORR was 13.7% superior (p < 0.0001) in patients with L-sarcoma compared with patients with non-L-sarcoma (16.6% vs. 9.0%). Median progression-free survival (PFS) was 5.1 months, whereas median overall survival (OS) was 21.6 months. Significantly better PFS and OS were observed in patients with L-sarcoma, those with objective responses and/or disease stabilization, treated in an early line and treated with reduced dose. Bone marrow toxicity (61.4%) and transaminase increases (21.9%) were the most common grade 3/4 adverse events. The results of this real-life study suggest that trabectedin is an active treatment, which is mostly given as a second-line treatment to patients with a good performance status and high-grade, metastatic L-sarcoma (clinical trial information: NCT02793050). Keywords: trabectedin; soft tissue sarcoma; real-life; observational 1. Introduction Soft tissue sarcomas (STS) are a heterogeneous group of more than 100 different mesenchymal malignancies arising from extraskeletal connective tissues, which repre- sent less than 2% of all adult tumors worldwide [1,2]. Despite radical en-bloc resection with curative intent, up to 30% of patients with localized sarcoma ultimately experience metastatic relapse at distant sites. Patients with advanced or metastatic sarcoma carry a poor prognosis, with an estimated median survival of approximately 1 year from the start of first-line anticancer therapy [3]. In patients with advanced disease, the optimum first-line treatment involves palliative systemic chemotherapy that has been unchanged for four decades and still consists of anthracycline-based chemotherapy [4]. After failure or intolerance of conventional front-line chemotherapy, the optimal sequencing of second-line options in the treatment algorithm for STS has not been well defined [5]. According to the European Society for Medical Oncology—European Reference Network for rare adult solid cancers (ESMO-EURACAN) Clinical Practice Guidelines, trabectedin is recommended for second- or beyond-line treatment for advanced STS after failure of anthracycline-based chemotherapy [2]. Cancers 2021, 13, 1053 3 of 15 Trabectedin (Yondelis®, PharmaMar, Madrid, Spain) is
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